Device product
Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
Z-2379-2016
Product summary
- Event
- Event 74773
- Status
- Terminated
- Classification
- Class II
- Quantity
- 93 sites have the affected version
- Official record key
device-enforcement:Z-2379-2016
Official wording
Reason: The patient name in the Halo title bar and the thumbnails do not match the name on displayed images.
Code information: Versions: V6.0.2.0 MR2 and earlier
Distribution pattern: The software was distributed to medical facilities nationwide. Government distribution was made to MN. Foreign distribution was made to Australia and to the United Kingdom. There was no military distribution.
Derived failure modes
-
Unknown
The patient name in the Halo title bar and the thumbnails do not match the name on displayed images.